CA1056683A

CA1056683A - Hydrophobic valve

Info

Publication number: CA1056683A
Application number: CA264,616A
Authority: CA
Inventors: Thurman S. Hjess
Original assignee: Baxter Travenol Laboratories Inc
Current assignee: Baxter International Inc
Priority date: 1975-11-03
Filing date: 1976-10-29
Publication date: 1979-06-19
Also published as: US3993062A; FR2329322A1; GB1552449A

Abstract

ABSTRACT OF THE DISCLOSURE

A hydrophobic valve for use with liquids, such as liquids for intravenous administration comprising a housing provided with inlet and outlet means, both of which communicate with the housing, a resilient, inflatable boot mounted in the housing and positioned to block the flow of liquid through the outlet means when inflated and to permit the flow of liquid through the outlet means when in a deflated position, with the boot including an open portion adjacent to the inlet means which is covered by a hydrophobic filter element capable of repelling liquid but permitting the passage of gases, such as air, therethrough whereby liquid introduced to the housing through the inlet means is passed through the housing for discharge from the outlet means and any air introduced with the liquid is passed through the hydrophobic filter into the boot to stop the flow of liquid from the outlet means when the boot is inflated with the gas.

Description

6~83 .~ , S P E C I F I C A T I O N
:

This invention relates to systems for the adminis-tration of intravenous liquids, and more particularly to ~3 valves for use in such systems.
~ It is well known in the administrat:ion of intra-r, venous liquids that care must be taken to a~oid the intro~
6 duction of air into the system which may be infused to a 7 patient. V~rious devices have been suggestad by the prior ~ ~
~ art to prevent the infusion of air, known in the art as ~;
~ air embolism. One approach which has been widely used lo involves the use of a filter which includes a hydrophilic : .
filter element which, when wetted with liquid, is capable of passing liquid therethrough while simultaneously blocking air. One such filter is described in U.S. Patent No. ;~
4 3,471,019. The filter described in that patent functions ~116 satisfac orily except when, in certain positions, an air l6 bubble present in the filter housing can be cau~ed to spread over the surface o~ the hydrophilic ilter element to thereby effectively cut off further fluid ~low. Thus, filters of 9 that type h~ve the disadvantage of being position sensitive, ~o that is, being incapable of proper operation when oriented in certain positions.
22 Another disadvantage of filters of the type as ~j 23 described in the foregoing patent stems from the fact that 24 no means are provided to stop fluid flow in the event the 25 hydrophilic filter element is ruptured. As will be appre- ~
`1~ 26 ciated by those skilled in the art, a rupture in the hydro- ~ `
7 philic filter element allows liquid and any air associated `~
~1 28 therewith to flow unimped~d through the system.

i, `I29 The prior art has attempted to provide filters `; `~

¦ 30 which either block or eliminate air in an intravenous , :
:. j , , , . " , ~ . . , . ... . .: ... ..

~L~5~83 administration system which are position insensitive. One such filter is described in U.S. Patent No. 3,5Z3,408.
There, the filter which is described as position insensitive is formed of hydrophobic and hydrophilic filter elements which must be closely spaced together, by a distance of the t; order of 0.5 to 2 ~n to insure that gas bubbles formed 7 between the two filter elements do not cause blockage of uid flow through the hydrophobic filter element. The -9 necessity for close spacing of the filter element itself represents a distinct disadvantage. In addition, filters :~ .
~' 1l of the type described in the latter patent are ren~ered ~
, . .~
totally inef~ective in the event there is a rupture in the hydrophilic filter element. ~`
4 It is accordingly an object of the present invention 15 to provide a valve suitable for use with intravenous 16 administration systems which is capable of blocking air 7 from passage therethrough.
It is a more specific object of the invention to provide a hydrophobic valve suitable for use in the intra-venous administration of liquids which is capable of blocking 21 air even though the filter element associated therewith may ~, 2~ be ruptured during use. -~
23 It is yet another object of the invention to provide 24 an intravenous administration system embodying the hydrophobic .. 25 valve of this invention.
, 26 These and other objects and advantages of the inven-:'. . '.~
' 27 tion will appear more fully hereinafter, and, for purposes 8 of illustration but not of limitation, an embodiment of the ; ~
invention is shown in the accompanying drawings wherein:
~ 30 FIGURE 1 is a side view in section of a valve ., .

.,. :
:' .

embodying the features of this invention;

2 FIGURE 2 is a side view in elevation of the embodi-

3 ment shown in FIGURE 1, with the valve in position to permit

4 liquid flow therethrough;
FIGURE 3 is a sectional view taken along the lines ` 6 3-3 in FIGURE l;
7 FIGURE 4 is a schematic illustration of an A intravenous administration set embodying the valve of this invention; and o FIGURE 5 is a schematic illustration of an alternative embodiment of an intravenous administration set including the valve of this invention.
The concepts o the present invention reside in a ' 1~ valve which includes a resilient, inflatable boot or diaphragm mounted in a housing equipped with both inlet and outlet means. ~ -1, lfi The resilient boot is open at its portion adjacent the inlet `~ l7 means to the housing, and the open portion is covered in a ~;
sealing relationship by a hydrophobic filter element capable 19 of repelling liquid but permitting the passage of air through the pores thereof.
When in the deflated state or position, the boot 22 is positioned in the housing such as to permit the passage 2:~ of liquid through the housing for discharge through the outlet 24 means. However, any air introduced with the liquid through the inlet means is passed through the hydrophobic filter into '~3 ' 2~ the boot whereby the boot, when inflated with air having passed through the hydrophobic filter, stops the flow of 1 28 liquid through the discharge means. In this way, the valve ~;j 29 of the present invention causes air or like gases associated with the liquid supplied to the valve through the inlet means :~.

~L~5~68~
~ ;
1 to be separated from the liquid and passed into the boot.
2 When the boot becomes inflated with the air or like gas, ,3 the boot stops the flow of liquid from the outlet means ;-4 to thereby prevent the passage of any significant amounts 6 of air through the valve.
~ 6 The hydrophobic valve of this invention operates '~ 7 independently of the position in which it is oriented, and '~
thus is position insensitive. In addition, if a hole or g rupture in the hydrophobic filter element should develop, liquid as well as gases can be passed into the boot to inflate the boot and thereby stop the flow of liquid through .l 12 the outlet means.
Having described the basic concepts of the present ~ 1~ invention, reference is now made to the accompanying drawings i! 15 for a more detailed description of the invention. There is ~ 16 shown in FIGURES 1 and 2 a hydrophobic valve embodying the ,,' 17 features of this invention including a housing generally 1 18 designated as lO and equipped with inlet means 12 through ;! -`~1 19 which a liquid is ~pplied to the housing and outlet means 14 ! 20 from which liquid is discharged from the housing. The 21 housing lO includes a generally cylindrical portion designated .~ 2'~ as 16 which terminates at its upper portion in a frusto- ^
; ~ . .
2'3 conical portion 18 communicating with the inlet means 12 and 24 the interior chamber 20 of the housiny. Similarly, the 25 housing lO includes a lower frusto-conical portion 22 -;~, 26 intermediate the housing and the outlet means 14 and ;~ 27 communicating therewith.
`~ ~ 28 As will be appreciated by those skilled in the i- , ..~ 29 art, the housing, including frusto-conical portions 18 and 1 30 22 as well as the inlet and outlet means l2 and 14, can ~e .` ! ~ ' ;`. 1 !~ ~ . ;, - :, made of any desired material. Frequently preferred are rigid plastics which can be molded by known, inexpensive :3 techniques. The frusto-conical portions 18 and 22 can be integral with or separate from the cylindrical portion 16.
6 For example, as is illustrated in FIGURES 1 and 2, the frusto-conical portion 18 is integral with the inlet means 7 12, and includes a peripheral annular flange 24 adapted to engage the cylindrical portion 16 of the housing 10 in a g sealing relationship. The frusto-conical portion 22 includes a similar flange 26 which likewise is engaged with the cylindrical wall of the housing 10 in a sealing relationship.
3 Positioned within the housing is a hydrophobic 14 filter support member 28 which is most clearly illustrated 15 in FIGURE 3 of the drawing. The filter support member 28 16 can be any desired shape, and is mounted adjacent to the 17 inlet means 12. In the preferred practice of this inven-l~ tion, as shown in FIGURES 1 and 2, the filter support member !1 28 is mounted on the cylindrical portion 16 of the housing 10 and is secured thereto by the overlaying flange member .
2~ The filter support member 28 has a configuration 3 such as to define one or more flow pathsbetween the interior Z4 30 of the frusto-conical portion 18 and the chamber 20 26 defined by the housing 10. As shown in FIGURE 3, the fi filter support member can be generally square in configuration 27 and dimensioned to correspond to the cross sec ion of the ~ housing 10. In this way, each of the four corners of the 29 filter support member 28 are positioned on the cylindrical . . .
~` 30 portion 16 of the housing 10, with the filter support member ~ ;' ' ~ ~S66&~3 ~

28 and the cylindrical por-tion 16 de~ining an openin~ or 2 flow path 32 bonded on one edge by the lateral edge of the . :I filter support member 28 and on the other edge by the ` 4 cylindrical portion 16 of the housing 10. .
.. ~ In the preferred practice of the invention as ~
', 6 shown in FIGURES 1 and 2, the filter support member 28 ~ :
!,~ 7 includes a generally central opening 34 defined by a R downwardly extending annular flange 36. The opening 34 is covered in a sealing relationship by the hydrophobic o filter element 38 overlying the support plate 28 or posi~
tioned within the opening 34. Such hydrophobic filter ~ ~.
:ii 12 elements are, of themselves, known to those skilled in : l:l the art; they are capable oE repelling liquids while ~.
l4 simultaneously passing air or like gases through the pores ;f Ir) thereof. Such hydrophobic filter elements are further '! 16 described in the foregoing U.S. patents. : -.' 17 Mounted on the filter support member 28 is an ::
inflatable boot 40. As is shown in FIGURE 1 of the drawing, the inflatable boot is open at its top portion 42, and is 2() mounted on the downwardly projecting annular flange 36 of the filter support member 28. The boot 40 is formed of a .~
material having an elastic memory, preferably an elastomeric ~.
2:3 material which is capable of being inflated. As is shown 24 in FIGURE 1, when the pressure in the chamber 44 defined by ~ .
25 the ~oot 40 equals the pressure in the chamber 20 defined ;
'~ 2fi by the housing 10, the boot 40 is inflated so as to engage :
1 27 the frusto-conical portion 22 adjacent the outlet means 14 ~ ~
`~ 28 in a sealing relationship to thereby block the flow of ~;
.i 29 liquid from the chamber 20 through the frusto-conical ~
.1 30 portion 22 to the outlet means 14. For this purpose, as .
,:
~ .
.~ 6 : :

6~3 I is perhaps most clearly shown in FIGURE 2 of the drawing, 2 the frusto-conical portion 22 includes a beveled valve ;3 seat 46 which is dimensioned to correspond to the lower 4 portion 48 of the boot 40 whereby the lower portion 48 forms

5 a fluid tight seal with the valve seat 46.
As is shown is FIGURE 2 of the drawing, when the 7 boot 40 is in the deflated state, that is the pressure in . A the boot 40 being less than the pressure in the chamber 20, no seal is formed between the lower portion of the boot o 40 and the valve seat 46 whereby liquid introduced to the Il inlet means 12 is capable of passage through the chamber 30 ~ ;~
12 defined by the upper frusto-conical portion 18 and through the flow paths 32 into the chamber 20 for passage through 14 the frusto-conical portion 22 for discharge through the . I5 outlet means 14. :
', lfi In the use of the valve of this invention, the boot :: 17 40 is collapsed, either manually or mechanically, to e~pel .,1 1# air from the boot and to permit liquid to flow through the ~ g housing 10 including the frusto-conical portion 22 for ~ ~o discharge through outlet means 14 as illustrated in FIGURE ~:
~, 21 2 of the drawing. While the boot is in the deflated state : . 22 as shown in FIGURE 2, the valve is filled with the liquid ~, 23 to be administered and the boot is released. Since the -chamber 20 is filled with liquid and only gasses such as air can pass through the hydrophobic filter element 38 ~-' 2fi into the interior 44 of the boot 40, the boot will remain collapsed as shown in FIGURE 2. Any air included with the liquid introduced to the inlet means 12 is drawn through :, ~: 29 the hydrophobic filter element 38 into the interlor 44 30 of the boot 40. When sufficient air has entered the ~, l~S6683 : .
interior 44 of the boot 40, the boot 40 will be inflated, that is the pressure in the chamber 44 will be equal to that in the chamber 20, and the lower portion 48 of the boot 40 will again form a seal with the valve set 46 to stop fi thè flow of liquid through the valve. In this way, inEusion : .
~; of air or like gases to the patient can be prevented.
.' 7 The hydrophobic valve of the present invention can be used with intravenous liquids, including blood and the like~ They are preferably used in combination with an o intravenous administration set of the type illustrated in ,. . .
1I FIGURE 4 of the drawing. As shown in that figure, the set t2 includes a hollow male connector 50 adapted to be connected to a source of an intravenous liquid (not shown in the drawing). To secure the connector 50 to the source of the ~` l5 liquid, the connector may be provided with a finger grip flange 52. The connector 50 thus communicates with a drip -~
17 chamber 54 into which the intravenous liquid is allowed to pass. From the drip chamber 54, the intravenous liquid ~
'lg passes through a second tubing means 56 to the valve of ; -this invention 58, such as a valve as shown in FIGURES 1-3.
.. ,., ~-: .
Liquid effluent from the valve passes through tubing means ~; 2~ 60 directly to the patient by way of an appropriate needle ~3 or like administration means 62 communicating therewith. ~ ~

However, it is likewise possible and sometimes desirable ~-25 to include with the administrat1on set a filter 64 to filter ``

any particular material from the liquid which has been passed Z 27 through the valve 58. Since the valve 58 prevents the 28 passage of gases such as air through the system, the filter 3 29 can simply be a particulate filter. - ;

~ 30 It is frequently desirable that the intravenous .:
-8 ~
,,.. , ~ :

16~5~6~3 I administration set include an injec-tion site for the purpose 2 of enabling medical preparations to be added to the system, ~3 independent of the liquid supplied to the drip chamber 5~.
For this purpose, one of the tubing means, such as the ;
r~ tubing means 56, is provided with a "Y" injection site

6 formed of a branch tube 66 communicating with the tubing

7 means 56 and terminating in an elastomeric injection plug A 68 through which a medical preparation can be injected by 9 way of a hypodermic syringe.
In many instances oE intravenous administration, it is desir~ble to employ pump means to control and/or 12 facilitate the delivery of the intravenous liquid to the patient. One such administration system is illustrated l~ in FIGURE 5 of the drawing. In that embodiment, the 16 administration set is generally the same as that shown in 16 FIGURE 4, except that the conduit means 56 between the drip 17 chamber 54 and the valve 58 of this invention includes pump 18 means generally designated as 70. In the embodiment ~`
9 illustrated in FIGURE 5, the pump means 70 is schematically 2() shown as a syringe pump, the details of which are well known l to those skilled in the art. As will also be appreciated 2~ by those skilled in the art, the syringe may be mechanically 3 driven, or, alternatively, may be replaced by any of a ~ `
24 variety of conventional mechanical pumps commercially 2~ available for pumping intravenous liquids It is also desirable in some instances to incorporate 1 ~ .
~l 27 the hydrophobic valve of this invention into a drip chamber.
i~ 2A For this purpose, the frusto-conical portion 18 at the top of the housing 10 can simply be omitted. In this variation of the invention, it is preferable to extend the cylindrical _g_ .. ,~ ' :~ . ~, .

` :
:

tii83 -i wall 16 of the housing 10 upwardly so as to define a drip . 2 chamber of the type shown in FIGURES 4 and 5, but having :3 the hydrophobic valve toward the bottom thereof. In this ~ ;
- 4 way, the hydrophobic valve of this invention shuts off 5 liquid flow from the drip chamber embodying the hydrophobic i 6 valve when the source of the intravenous liquid supplying ; 7 the drip chamber empties. Flow of intravenous liquid

8 through the drip chamber can simply be restarted by providing ~ :
; g a fresh source of intravenous liquid and deflating the boot, ~
10 thereby completely avoiding repriming of the set. ~- :
It will be understood that various changes and :~
2 modifications can be made in the details o~ construction, :~
' 1 "i ~, .
procedure and use without departing from the spirit of the .l 14 invention, especially as defined in the following claims. ~ .
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i 28 j 29 .; 1 ::1:
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Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A hydrophobic valve for liquids comprising:
(a) a housing defining inlet means and outlet means, each of the inlet and outlet means communicating with the housing (b) a resilient, inflatable boot mounted in the housing, said boot positioned to block the flow of liquid through the outlet means when inflated and to permit flow the liquid through the outlet means when in a deflated state, said boot including an open portion adjacent to the inlet means, and (c) a hydrophobic filter element capable of repelling liquid but permitting the passage of air therethrough positioned over said open portion adjacent to the inlet means whereby liquid introduced to the housing through the inlet means is passed through the housing for discharge from the outlet means and air introduced with the liquid is passed through the hydrophobic filter into the boot to stop the flow of liquid when the boot is inflated with air.

2. A valve as defined in claim 1 wherein the housing includes a generally cylindrical portion, with the housing including a frusto-conical portion adjacent to the inlet means integral with the cylindrical portion of the housing.

3. A valve as defined in claim 2 wherein the hydrophobic filter is centrally mounted adjacent to the frusto-conical portion, with the hydrophobic filter and the housing defining a flow path therebetween whereby liquid introduced to the housing through the inlet means is repelled by the hydrophobic filter and is passed through the flow paths for discharge from the housing through the outlet means.

4. A valve as defined in claim 1 which includes filter support means mounted on the cylindrical portion of the housing, said hydrophobic filter being mounted thereon, with the filter support means being dimensioned to define said flow paths between the filter support means and the cylindrical portion of the housing.

5. A valve as defined in claim 1 wherein the housing includes a second frusto-conical section adjacent to the outlet means, said second frusto-conical section defining a valve seat, with the boot including a lower portion corresponding, when inflated with fluid, to the valve seat whereby the boot forms a seal with the valve seat to prevent the flow of liquid through the outlet means.

6. In an administration set for the administration of intravenous liquids comprising a drip chamber adapted to receive intravenous liquid from a source of said liquid and administration means for infusing the liquid from the drip chamber to a patient, the improvement comprising a hydro-phobic valve interposed between the drip chamber and said means, said hydrophobic valve comprising:
(a) a housing defining inlet means and outlet means, each of the inlet and outlet means communicating with the housing (b) a resilient, inflatable boot mounted in the housing, said boot positioned to block the flow of liquid through the outlet means when inflated and to permit flow of liquid through the outlet means when in a deflated state, said boot including an open portion adjacent to the inlet means, and (c) a hydrophobic filter element capable of repelling liquid but permitting the passage of air therethrough positioned over said open portion adjacent to the inlet means whereby liquid introduced to the housing through the inlet means is passed through the housing for discharge from the outlet means and air introduced with the liquid is passed through the hydrophobic filter into the boot to stop the flow of liquid when the boot is inflated with air.

7. A set as defined in claim 6 wherein the housing includes a generally cylindrical portion, with the housing including a frusto-conical portion adjacent to the inlet means integral with the cylindrical portion of the housing.

8. A set as defined in claim 6 wherein the hydrophobic filter is centrally mounted adjacent to the frusto-conical portion, with the hydrophobic filter and the housing defining a flow path therebetween whereby liquid introduced to the housing through the inlet means is repelled by the hydrophobic filter and is passed through the flow paths for discharge from the housing through the outlet means.

9. A set as defined in claim 6 which includes filter support means mounted on the cylindrical portion of the housing, said hydrophobic filter being mounted thereon, with the filter support means being dimensioned to define said flow paths between the filter support means and the cylindrical portion of the housing.

10. A set as defined in claim 6 wherein the housing includes a second frusto-conical section adjacent to the outlet means, said second frusto-conical section defining a valve seat, with the boot including a lower portion corresponding, when inflated with fluid, to the valve seat whereby the boot forms a seal with the valve seat to prevent the flow of liquid through the outlet means.

11. A set as defined in claim 6 which includes an in-line filter for filtering the intravenous liquid prior to infusing said liquid to a patient.

12. A set as defined in claim 6 wherein the hydrophobic valve is integral with the drip chamber, and is positioned at the lower end thereof whereby the hydro-phobic valve serves to shut off liquid from the drip chamber when said source empties.